FDA Inspection 1200814 — Tesla Biohealing, Inc.
The FDA completed an inspection of Tesla Biohealing, Inc. on Mar 23, 2023 in Milford, DE. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 23, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Milford, DE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |